Clinical trials: Tolerability
Spinal Muscular Atrophy
A Study to Assess the Safety and Tolerability of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA).
The primary objective of Part 1 of this study is to assess the safety and tolerability of Nusinersen in participants with SMA who are not eligible to participate in the clinical studies ISIS 396443-CS3B (NCT02193074) or ISIS…
- Trial name
- EMBRACE (NCT02462759)
- Testing
- Nusinersen
- Where
- 7 sites in United States, Germany
- Volunteers
- 21 people
- Sponsor
- Biogen
Vaccines, Pneumococcal
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccinations…
- Trial name
- NCT00368966
- Testing
- 13-valent Pneumococcal Conjugate Vaccine, 7-valent Pneumococcal Conjugate Vaccine
- Where
- 41 sites in Spain
- Volunteers
- 619 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Asthma
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- Trial name
- NCT03560466
- Testing
- Dupilumab (SAR231893/REGN668), Asthma controller therapies (incl. prednisone/prednisolone), Asthma reliever therapies
- Where
- 81 sites in United States, Argentina and 16 more
- Volunteers
- 378 people
- Sponsor
- Sanofi
Acute Lymphoblastic Leukemia
Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and to assess whether this…
- Trial name
- NCT01471782
- Testing
- Blinatumomab
- Where
- 30 sites in United States, Austria and 5 more
- Volunteers
- 93 people
- Sponsor
- Amgen Research (Munich) GmbH
Healthy Subjects
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group 1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP), Group 2: 7-valent…
- Trial name
- NCT01200368
- Testing
- 13-valent pneumococcal conjugate vaccine (13vPnC), diphtheria, tetanus, and acellular pertussis vaccine (DTaP), 7-valent pneumococcal conjugate vaccine (7vPnC)
- Where
- 32 sites in Japan
- Volunteers
- 551 people
- Sponsor
- Pfizer
Primary Haemophagocytic Lymphohistiocytosis
Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis
The purpose of this study is to assess the safety, tolerability and efficacy of a new drug aimed at controlling disease activity in patients diagnosed with primary haemophagocytic lymphohistiocytosis.
- Trial name
- NCT01818492
- Testing
- NI-0501
- Where
- 20 sites in United States, Germany and 4 more
- Volunteers
- 45 people
- Sponsor
- Swedish Orphan Biovitrum
Healthy
Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years
The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine (TDV) (previously DENVax) administered subcutaneously in healthy adults and children.
- Trial name
- NCT01511250
- Testing
- TDV
- Where
- 8 sites in Colombia, Puerto Rico and 2 more
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Takeda
Sickle Cell Anemia
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia
The study assesses the efficacy, safety and tolerability of ACZ885 (canakinumab) in pediatric and young adult patients with sickle cell anemia (SCA).
- Trial name
- NCT02961218
- Testing
- ACZ885
- Where
- 15 sites in United States, Canada and 5 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
Influenza
Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years
The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.
- Trial name
- NCT00372255
- Testing
- Influsplit SSW® 2005/2006
- Where
- 18 sites in Germany
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
AL Amyloidosis
Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis
The rationale for this study is to provide additional treatment with NEOD001 for subjects who complete Study NEOD001-001, and to continue to evaluate long term safety and tolerability.
- Trial name
- OLE (NCT02613182)
- Testing
- NEOD001
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Prothena Biosciences Ltd.
Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial
Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children.
- Conditions
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria
- Trial name
- NCT00761527
- Testing
- Desloratadine Syrup
- Volunteers
- 2,980 people
- Sponsor
- Organon and Co
Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone)
A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily.
- Conditions
- Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone), Endocrine System Diseases, Hormones
- Trial name
- NCT02781727
- Testing
- Once weekly subcutaneous injection of TransCon hGH, Once daily subcutaneous injection of Genotropin
- Where
- 53 sites in United States, Armenia and 12 more
- Volunteers
- 162 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Neutropenia
Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)
This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered intravenously (IV) or orally to immunocompromised pediatric participants.
- Trial name
- NCT02452034
- Testing
- Posaconazole IV solution, Posaconazole powder for oral suspension
- Volunteers
- 118 people
- Sponsor
- Merck Sharp & Dohme LLC
MENINGOCOCCAL INFECTION
A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years
This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young children.
- Trial name
- NCT02531698
- Testing
- Bivalent rLP2086 Vaccine, Licensed pediatric hepatits A vaccine, Normal Saline
- Where
- 15 sites in Finland, Poland
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Pfizer
Asthma
Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma
The purpose of this study was to assess the pharmacokinetics (PK) of fevipiprant (QAW039) delivered as a chewable tablet (CT) in pediatric asthma subjects aged 6 to < 12 years with asthma.
- Trial name
- NCT03650400
- Testing
- Fevipiprant
- Where
- 6 sites in United States
- Volunteers
- 11 people
- Sponsor
- Novartis Pharmaceuticals
Alopecia Areata
A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata
Primary: To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical Solution, compared to vehicle in subjects with alopecia areata (AA) Secondary: To evaluate key clinical outcome assessments
- Trial name
- NCT03354637
- Testing
- ATI-50002 high dose, ATI-50002 low dose
- Where
- 23 sites in United States
- Volunteers
- 129 people
- Sponsor
- Aclaris Therapeutics, Inc.
Migraine
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM).
- Trial name
- NCT04458857
- Testing
- Fremanezumab
- Where
- 89 sites in United States, Canada and 7 more
- Volunteers
- 235 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Antibody-mediated Rejection, Kidney Transplant; Complications
Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant
Antibody mediated rejection (ABMR) is a unique, significant and often severe form of allograft rejection. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling ten patients with biopsy…
- Conditions
- Antibody-mediated Rejection, Kidney Transplant; Complications, Transplant Glomerulopathy, Transplant Glomerulopathy - Late Form
- Trial name
- NCT03380377
- Testing
- Clazakizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Stanley Jordan, MD
Asthma
A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Combination Dry Powder of Fluticasone Propionate and Salmeterol (FSC) 250/50 Microgram (mcg) Twice Daily (BID) in Adults and Adolescents With Asthma
This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 week non inferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg capsule-based inhaler and FSC 250/50 mcg…
- Trial name
- NCT01978119
- Testing
- FSC
- Where
- 13 sites in Russia, Ukraine
- Volunteers
- 124 people
- Sponsor
- GlaxoSmithKline
Systemic Infections
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections
To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to <18 years.
- Trial name
- NCT01893346
- Testing
- CAZ-AVI
- Where
- 10 sites in United States
- Volunteers
- 35 people
- Sponsor
- Pfizer